SGMO » Topics » Article 1. Definitions

This excerpt taken from the SGMO 10-Q filed May 9, 2008.

Article 1. Definitions

Capitalized terms used in this Agreement, whether used in the singular or plural, shall have the meanings set forth below, unless otherwise specifically indicated herein. This Agreement and the First Agreement use many of the same defined terms. Unless the First Agreement is expressly referenced, the use of a given term in this Agreement only refers to this Agreement.

1.1 “Accept the [***] Evidence (and grammatical variations thereof) shall be defined in the Research Plan for a given Designated Gene if Sangamo has an obligation under such Research Plan to attempt to generate one or more Modified Genentech CHO Cell Lines with respect to such Designated Gene. “Accept the [***] Evidence” includes those cases in which Genentech is deemed to Accept the [***] Evidence (including, without limitation, under Section 2.4).

 

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1.2 Affiliate means, with respect to a particular Party, a person, corporation, partnership, or other entity that controls, is controlled by or is under common control with such Party. For the purposes of this definition, the word “control” (including, with correlative meaning, the terms “controlled by” or “under the common control with”) means (a) the direct or indirect ownership of fifty percent (50%) or more of the stock having the right to vote for directors thereof; or (b) the actual power, either directly or indirectly through one or more intermediaries, to direct the management and policies of such entity, whether by the ownership of at least fifty percent (50%) of the voting stock of such entity, or by contract or otherwise.

1.3 “[***] Evidence shall be defined in the Research Plan for a given Designated Gene if Sangamo has an obligation under such Research Plan to attempt to generate one or more Modified Genentech CHO Cell Lines with respect to such Designated Gene.

1.4 “Approval of the Research Plan is defined in Section 2.1(d).

1.5 “Assumption Agreement means a written agreement, executed by Genentech, Sangamo and [***], under which [***]. An Assumption Agreement may include reasonable modifications to this Agreement and/or the [***] Agreement, as necessary to reflect the [***]; provided, however, unless otherwise agreed to by Genentech, Sangamo and [***], the [***] obligations under this Agreement that may be delegated to [***] under an Assumption Agreement shall be limited to those related to the performance of a [***]. Further, in no event, shall an Assumption Agreement in any way increase Genentech’s financial or other obligations under this Agreement or adversely affect the Genentech License or other licenses and rights granted to Genentech under this Agreement.

1.6 “BLA means a Biologics License Application or other such application (other than a supplemental application) filed with the U.S. Food and Drug Administration (or any successor entity thereto performing similar functions) for the purpose of obtaining Marketing Approval for a Licensed Product in the United States.

1.7 “Caltech Agreement means the Third Party License between Sangamo and the California Institute of Technology, dated November 1, 2003, as amended as of the Effective Date, and prior to any amendments after the Effective Date.

1.8 “CHO means Chinese hamster ovary.

1.9 “Collaboration Partner means, with respect to a given Licensed Product, a Third Party to which Genentech has granted a license to use, sell, offer for sale and/or import such Licensed Product, whether or not such license includes the right to make such Licensed Product.

1.10 “Commercially Diligent Efforts means, (a) with respect to Sangamo, efforts and resources comparable to those expended by Sangamo on its projects for a Third Party of a similar nature (i.e., protein production projects) and (b) with respect to Genentech, efforts and resources comparable to those expended by Genentech on its internal process development projects of comparable value to Genentech.

 

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1.11 Confidential Informationmeans a Party’s nonpublic information that is disclosed to the other Party in connection with this Agreement (including, without limitation, information regarding such Party’s research, technology, assays, protocols, methods, processes, data, products and business information or objectives), provided that any such information disclosed in written, electronic or other tangible form is marked as “confidential” or with a similar legend. For clarity, Sangamo may disclose to Genentech certain nonpublic information that was originally disclosed to Sangamo by [***], and such nonpublic information shall be deemed to be the nonpublic information of Sangamo for the purpose of this definition. Nonpublic information of a Party that is disclosed other than in tangible form (e.g., disclosed orally or by observation of the other Party) shall be considered Confidential Information of such Party only if so identified in writing to the other Party within thirty (30) days after initial disclosure and such writing identifies such Confidential Information with particularity. Notwithstanding the foregoing marking requirement, Genentech’s Confidential Information shall include (a) the Maximum Number of Genes and the actual number of Designated Genes; (b) the identity of the Requested Genes and the Designated Genes (as the focus of this Agreement) and the Functional [***] thereof; (c) Genentech’s interest in the Requested Genes and the Designated Genes as potential targets for modification to improve production cell lines; (d) the Research Plan and Draft Research Plans; (e) the Research Results; and (f) all information in the Genentech Deliverables, whether or not any of the foregoing information in (a) through (f) is so marked. The terms and conditions of this Agreement (including, without limitation, the financial terms) shall be the Confidential Information of both Parties.

1.12 “Controlled by means the rightful possession by a Party of the ability to grant a license, sublicense or other right to exploit, as provided in this Agreement, without violating the terms of any agreement with any Third Party.

1.13 “Covering (and grammatical variations thereof) means that, with respect to a given Licensed Product, a protein contained in such Licensed Product was expressed by a Modified Cell Line and (a) the making or use of such Modified Cell Line fell within the scope of a Valid Claim (in the country of such making or use) at the time of such making or use; and/or (b) if such Modified Cell Line is a ZFN Modified Cell Line, the making or use of a ZFN Reagent used to create such Modified Cell Line fell within the scope of a Valid Claim (in the country of such making or use) at the time of such making or use.

1.14 “Delegated Obligations is defined in Section 14.2(d).

1.15 “Designated Gene means a Requested Gene that is included as a Designated Gene under Section 2.1(e) and which is further defined by the Designated Gene Sequence for such Designated Gene.

1.16 “Designated Gene Sequence means the partial or full cDNA coding sequence from a CHO cell line for a given Designated Gene, as specified under Section 2.1(e)(i) (in the case of a Request for Existing ZFN Reagents) or Section 2.1(e)(ii) (in the case of an Approval of the Research Plan), as applicable.

 

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1.17 Donor Sequence means, with respect to a given Designated Gene, a DNA sequence sharing homology with sequences upstream and downstream of a ZFN cutting site in such Designated Gene, where such sequences are of sufficient length [***] to allow homologous recombination to occur at an efficiency of [***] . The Donor Sequence for a given Designated Gene shall also contain a DNA sequence for insertion into such Designated Gene via homologous recombination, and such DNA sequence may contain [***] as agreed to by the Liaisons.

1.18 “Draft Research Plan means a draft of a research plan for the research activities to be performed by the Parties under this Agreement, which shall be based on the Research Plan Template to the extent applicable, prior to approval by Genentech under Section 2.1(d).

1.19 “Excluded ZFN Reagents Know-How is defined in Section 2.1(b)(ii).

1.20 “Executive means, in the case of Sangamo, its Chief Executive Officer and, in the case of Genentech, a Senior Vice President, or their respective designees. Notwithstanding the foregoing, in the event of a dispute arising under Section 2.4(c), “Executive” means, in the case of Sangamo, its Chief Scientific Officer and, in the case of Genentech, its Vice President of Process Development.

1.21 “Existing [***] Evidence means, with respect to given Existing ZFN Reagents, a data package and summary for such Existing ZFN Reagents (that Sangamo has the right to provide to Genentech), including evidence that the Requested Gene/Designated Gene has been Functionally [***] in a CHO cell line as specified in the Genentech Request Notice for such Requested Gene.

1.22 “Existing Third Party Licenses means the Caltech Agreement, the JHU Agreement, the MIT Agreement, the Scripps Agreement, the Sigma Agreement and the Utah Agreement.

1.23 “Existing ZFN Reagents is defined in Section 2.1(b)(ii).

1.24 “Existing ZFN Reagents Know-How means, with respect to given Existing ZFN Reagents, at the time Sangamo offers to provide such Existing ZFN Reagents to Genentech, any then-existing tangible manifestations of Sangamo Know-How, to the extent reasonably accessible to Sangamo personnel and reasonably ascertainable as relevant to such Existing ZFN Reagents, but in all cases including (i.e., whether or not then-existing as tangible manifestations, reasonably accessible, etc.) the following “required” information: (a) written protocols for the methods and assays used to generate all of the Existing [***] Evidence and (b) written protocols for the use of such Existing ZFN Reagents to generate ZFN Modified Cell Lines.

1.25 “Expression Plasmid means an appropriate expression plasmid in the form of [***] of purified plasmid DNA for each ZFN Reagent in TE buffer.

1.26 “First Agreement means the Research and License Agreement between Genentech and Sangamo, dated April 27, 2007, including any amendments thereafter.

 

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1.27 First Commercial Sale means the first bona fide commercial sale of a product in a country following Marketing Approval for such product in such country by or under authority of Genentech or its sublicensees.

1.28 “FTE means the equivalent of the work of one Sangamo employee full-time for a twelve (12) month period (consisting of at least a total of [***] hours) of work directly related to activities under the Research Plan or training requested by Genentech (e.g., under Section 2.6(c) or Section 2.1(e)(i)), including experimental laboratory work, recording and writing up results, reviewing literature and references and participating in scientific discussions with the Genentech Liaison. For any payment under this Agreement made on the basis of an FTE, no additional payment shall be made with respect to any individual who works more than [***] hours in any twelve (12) month period, and any person who devotes less than [***] hours in any twelve (12) month period shall be treated as an FTE on a pro-rata basis based upon the actual number of hours worked divided by [***].

1.29 “FTE Rate means a fully-loaded rate of [***] per FTE per year, and incorporates all Sangamo internal and external costs for performing its obligations under the Research Plan and any other activities for which the FTE Rate applies.

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